Thoracic Aortic AneurysmMAFATSNCT05650892
Male-female Differences in Immunohistological and Biomechanical Properties of the Thoracic Aorta
An observational study of Thoracic Aortic Aneurysm, run by Hanneke Takkenberg at 1 site in Netherlands.
Trial summary
Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2021to 12 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years old) who will undergo or already underwent elective surgery for thoracic aortic aneurysm at Erasmus MC, Rotterdam and LUMC, Leiden.
Who may be able to join
- Adult patients (≥ 18 years old) who have a thoracic aortic aneurysm and are scheduled for elective thoracic aortic surgery in the Erasmus MC or the LUMC.
Who cannot join
- Patients with a known connective tissue disease (e.g. Marfan Syndrome and Ehlers-Danlos syndromes).
- Connective tissue disease,
Trial locations and contacts
1 site in 1 country.
About this study
Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men (1). The mechanisms for these male-female difference in TAA outcome remain, however, unclear. The timing of preventive surgery is now not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be needed.
Read the detailed description
Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men(1). However, the mechanisms for these male-female differences in TAA outcome remain unclear. The timing of preventive surgery is not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be beneficial for outcome.
The current research project aims to implement male-female specific insights into aortic root and ascending aorta characteristics into clinical practice, allowing better identification of high risk Thoracic Aortic Aneurysm (TAA) patients and better timing of intervention. With this study the investigators aim to obtain insight into male-female differences in the immunohistological and biomechanical properties of the thoracic aortic wall. In order to reveal possible mechanisms for male-female differences in TAA.
- Conditions
- Thoracic Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sample collection aortic tissue | Sample collection thoracic aorta tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Male-female differences in immunohistochemical and mass spectrometry-based estrogen and testosterone receptor expression levels (and density) in the proximal aortic wall
To investigate male-female differences in estrogen receptor (ESR-alpha and ESRbeta) and testosterone receptor (AR) tissue expression in the wall of the aortic root and ascending aorta by immunohistochemical techniques and mass spectometry. Comparisons will be made using a students t-test.
Measured: 1 year
Secondary outcomes (1)
Male-female differences in immunohistochemical or mass spectrometry-based sex hormone receptor expression levels (and density) in the proximal aortic wall.
To perform an explorative analysis of differences in sex hormone receptor expression in the relation to 1) the immunohistological properties of the aortic wall structure (smooth muscle cell differentiation, presence of macrophages, endothelial cell activation and extracellular matrix, through the following markers: alpha smooth muscle actin, sex hormone receptors (ESR1, RAGE, MMP 2, 3 and 9 and aromatase expression as marker for estrogen synthesis in SMC in both male and female), presence of macrophages (CD68 and MAC2) and endothelial cell activation (NOS3, TGF-β signaling) and extracellular matrix (a.o. fibrillin 1, elastin, collagen and crosslinking)) and to (1) sex hormone (androstenedione, DHEA, testosterone and SHBG in nmol/L, LH and FSH in IU/L, DHEA-S in micromole/L, AMH in micrograms/L, estradiol in picomol/L) and sRAGE (picograms/L) levels in blood, (2) aortic diameter (in millimeters) and (3) age (in years) using linear regression models.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Feb 2021
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanneke Takkenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanneke Takkenberg, Erasmus Medical Center
- Investigators
- Hanneke Takkenberg, Prof. dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650892
- Sponsor's protocol ID
- MEC-2020-0085
- Acronym
- MAFATS
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All our anonymised individual patient data (IPD) will be available to other researchers, upon reasonable request and after publication of the manuscript. This includes IPD derived from all analyses that were performed for and used in this study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male-female Differences in Immunohistological and Biomechanical Properties of the Thoracic Aorta
- ClinicalTrials.gov ID
- NCT05650892
- Acronym / sponsor ID
- MAFATS / MEC-2020-0085
- Conditions
- Thoracic Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hanneke TakkenbergUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men (1). The mechanisms for these male-female difference in TAA outcome remain, however, unclear. The timing of preventive surgery is now not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be needed.
Detailed description
Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men(1). However, the mechanisms for these male-female differences in TAA outcome remain unclear. The timing of preventive surgery is not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be beneficial for outcome.
The current research project aims to implement male-female specific insights into aortic root and ascending aorta characteristics into clinical practice, allowing better identification of high risk Thoracic Aortic Aneurysm (TAA) patients and better timing of intervention. With this study the investigators aim to obtain insight into male-female differences in the immunohistological and biomechanical properties of the thoracic aortic wall. In order to reveal possible mechanisms for male-female differences in TAA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample collection aortic tissue | – | –Sample collection thoracic aorta tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years old) who will undergo or already underwent elective surgery for thoracic aortic aneurysm at Erasmus MC, Rotterdam and LUMC, Leiden.
Key inclusion criteria (1 listed)
- Adult patients (≥ 18 years old) who have a thoracic aortic aneurysm and are scheduled for elective thoracic aortic surgery in the Erasmus MC or the LUMC.
Key exclusion criteria (2 listed)
- Patients with a known connective tissue disease (e.g. Marfan Syndrome and Ehlers-Danlos syndromes).
- Connective tissue disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Male-female differences in immunohistochemical and mass spectrometry-based estrogen and testosterone receptor expression levels (and density) in the proximal aortic wall
Time frame: 1 year
To investigate male-female differences in estrogen receptor (ESR-alpha and ESRbeta) and testosterone receptor (AR) tissue expression in the wall of the aortic root and ascending aorta by immunohistochemical techniques and mass spectometry. Comparisons will be made using a students t-test.
1 secondary outcome
Male-female differences in immunohistochemical or mass spectrometry-based sex hormone receptor expression levels (and density) in the proximal aortic wall.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. All our anonymised individual patient data (IPD) will be available to other researchers, upon reasonable request and after publication of the manuscript. This includes IPD derived from all analyses that were performed for and used in this study.
Related trials for Thoracic Aortic Aneurysm
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanneke Takkenberg, Prof. dr. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm, run by Hanneke Takkenberg at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Male-female differences in immunohistochemical and mass spectrometry-based estrogen and testosterone receptor expression levels (and density) in the proximal aortic wall (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.